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Model 5866-37M Lead Adaptor Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K904575

by Medtronic Vascular

Identifiers

510(k) Number
K904575 FDA 510(k)
FDA Product Code
DTD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3620 FDA 510(k)
Regulation Number
870.3620 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model 5866-37M Lead Adaptor Kit is a medical device designed to connect pacemaker leads to pacing systems. It is classified as a Pacemaker Lead Adaptor under FDA device class 2.

This kit is supplied sterile and intended for single-use in clinical settings. It is MRI safe and must be stored according to manufacturer guidelines. The device has received FDA 510(k) clearance (K904575) as a substantially equivalent product.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K904575 FDA 510(k) - MODEL 5866-37M LEAD ADAPTOR KIT, MODEL 5866-37M LEAD ADAPTOR KIT - fda.innolitics.com, PDF K904575 - Model 5866-37m Lead Adaptor Kit, Model 5866-37m Lead Adaptor Kit 510 (k) FDA Premarket Notification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K904575 24 fields · synced Oct 6, 2026